MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE® REVERSE SHOULDER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	405800
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: associated product information, part (lot): 110032420 (67246588) 115396 (67418205) 180551 (67420640) 180552 (67421276) 180552 (67421250) 180553 (67421682) 115320 (65992621) 115320 (67220435) xl-115366 (628080) g2: foreign - event occurred in united kingdom.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that during a revision reverse shoulder arthroplasty, bone grafting of the glenoid was performed to restore bone stock.During re-preparation of the glenoid, a threaded steinman pin fractured at the distal tip.The distal fragment was left in situ due to its position and inability to be safely retrieved.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The reported event was confirmed by review of x-rays.Right reverse total shoulder arthroplasty exhibiting standard alignment and position.A retained broken-off steinman screw tip projects the superior scapula, medial to the suprascuplar notch on ap projection.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: COMPREHENSIVE® REVERSE SHOULDER
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23582534
• Report Number: 0001825034-2025-03675
• Device Sequence Number: 9378071
• Product Code: PHX
• UDI-Device Identifier: 00887868504563
• UDI-Public: (01)00887868504563(17)350606(10)67367224
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 405800
• Device Lot Number: 67367224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male